Postnatal Adaptation and Stress in Healthy Newborns Born by Cesarean SectionAFO-NASNCT07736235
Effect of Amniotic Fluid Odor on Newborn Adaptation and Stress (AFO-NAS)
A study testing Amniotic Fluid Odor Sterile Distilled Water Odor in people with Postnatal Adaptation and Stress in Healthy Newborns Born by Cesarean Section, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to determine whether exposure to the odor of a newborn's own amniotic fluid affects postnatal adaptation and stress in healthy newborns born by cesarean section. Newborns will be randomly assigned to either an intervention group or a control group. Read more about this study
- Who is it for?
- Ages 38 to 42 weeksHealthy volunteers can take part
- Conditions the study is for
- Postnatal Adaptation and Stress in Healthy Newborns Born by Cesarean Section
- What is being tested?
- Amniotic Fluid Odor Sterile Distilled Water Odor
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Dec 2022to 15 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 38 to 42 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Newborns delivered by cesarean section at 38-42 weeks of gestation
- Absence of a maternal history of high-risk pregnancy, including eclampsia, preeclampsia, or gestational diabetes
Who cannot join
- Birth weight below 2,500 g
- Birth weight of 4,000 g or above
- Apgar score below 7 at either 1 or 5 minutes after birth
- Presence of a congenital anomaly
- Admission to the neonatal intensive care unit during the early postnatal period
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aydın Adnan Menderes University
Aydin, Efeler, 09100
About this study
Official title: The Effect of Amniotic Fluid Odor on Postnatal Adaptation and Stress in Healthy Newborns Born by Cesarean Section
This study aims to determine whether exposure to the odor of a newborn's own amniotic fluid affects postnatal adaptation and stress in healthy newborns born by cesarean section. Newborns will be randomly assigned to either an intervention group or a control group. Newborns in the intervention group will be exposed to a sterile material moistened with their own amniotic fluid, while newborns in the control group will be exposed to a sterile material moistened with distilled water. Postnatal adaptation, physiological responses, and stress levels will be evaluated at predetermined time points.
- Being tested
- Amniotic Fluid Odor Sterile Distilled Water Odor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amniotic Fluid Odor Sterile Distilled Water OdorOther
In the intervention group, healthy newborns born by cesarean section will be exposed to the odor of their own amniotic fluid shortly after birth. Amniotic fluid collected during delivery will be applied to a sterile material and positioned near the newborn's nose without direct contact with the skin or airway. The intervention will be administered according to a standardized study protocol. The newborns' postnatal adaptation, physiological parameters, and stress responses will be assessed at predetermined time points.
| Study group | Role | What they receive |
|---|---|---|
| Amniotic Fluid Odor Group | Experimental | Healthy newborns born by cesarean section in this arm will be exposed to the odor of their own amniotic fluid following birth. Postnatal adaptation and stress responses will be evaluated according to the study protocol. Receives: Other: Amniotic Fluid Odor Sterile Distilled Water Odor |
| Distilled Water Odor Exposure | Placebo comparator | Healthy newborns born by cesarean section in this arm will be exposed to a sterile material moistened with distilled water following birth. Postnatal adaptation and stress responses will be evaluated according to the study protocol. Receives: Other: Amniotic Fluid Odor Sterile Distilled Water Odor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate:beats per minute
The newborn's heart rate will be measured using a pulse oximeter and recorded as beats per minute. Heart rate values will be compared between the amniotic fluid odor group and the sterile distilled water odor group.
Measured: At 30 minutes after birth
Respiratory Rate: breaths per minute
The newborn's respiratory rate will be assessed by counting respiratory movements for one minute and recorded as breaths per minute. Respiratory rate values will be compared between the study groups.
Measured: At 30 minutes after birth
Peripheral Oxygen Saturation:percentage
The newborn's peripheral oxygen saturation will be measured using a pulse oximeter and recorded as a percentage. Oxygen saturation values will be compared between the study groups.
Measured: At 30 minutes after birth
Body Temperature: degrees Celsius
The newborn's body temperature will be measured using a digital thermometer and recorded in degrees Celsius. Body temperature values will be compared between the study groups.
Measured: At 30 minutes after birth
Secondary outcomes (1)
Neonatal Stress Level
Neonatal stress will be assessed using the Neonatal Stress Scale developed by Ceylan and Bolışık. The scale consists of eight subgroups: facial expression, body color, respiration, activity level, consolability, muscle tone, extremities, and posture. Each subgroup is scored from 0 to 2, resulting in a total score ranging from 0 to 16. A score of 0 indicates no stress, and higher scores indicate a higher level of neonatal stress and therefore a worse outcome.
Measured: 30 minutes after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start16 Dec 2022
- Primary completion15 Aug 2026
- Study completion15 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postnatal Adaptation and Stress in Healthy Newborns Born by Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Funda Güler, Aydin Adnan Menderes University
- Investigators
- zekiye karaçam, prof, Study chair, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736235
- Sponsor's protocol ID
- ADU-AMNION
- Acronym
- AFO-NAS
- Status last verified
- Oct 2026
- First submitted
- 24 Jul 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Amniotic Fluid Odor on Postnatal Adaptation and Stress in Healthy Newborns Born by Cesarean Section
- ClinicalTrials.gov ID
- NCT07736235
- Acronym / sponsor ID
- AFO-NAS / ADU-AMNION
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 16 Dec 2022 (actual)
- Primary completion
- 15 Aug 2026 (actual)
- Study completion
- 15 Aug 2026 (actual)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine whether exposure to the odor of a newborn's own amniotic fluid affects postnatal adaptation and stress in healthy newborns born by cesarean section. Newborns will be randomly assigned to either an intervention group or a control group. Newborns in the intervention group will be exposed to a sterile material moistened with their own amniotic fluid, while newborns in the control group will be exposed to a sterile material moistened with distilled water. Postnatal adaptation, physiological responses, and stress levels will be evaluated at predetermined time points.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amniotic Fluid Odor Group | Experimental | Other: Amniotic Fluid Odor Sterile Distilled Water OdorHealthy newborns born by cesarean section in this arm will be exposed to the odor of their own amniotic fluid following birth. Postnatal adaptation and stress responses will be evaluated according to the study protocol. |
| Distilled Water Odor Exposure | Placebo comparator | Other: Amniotic Fluid Odor Sterile Distilled Water OdorHealthy newborns born by cesarean section in this arm will be exposed to a sterile material moistened with distilled water following birth. Postnatal adaptation and stress responses will be evaluated according to the study protocol. |
Who may qualify
- Ages
- 38 to 42 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Newborns delivered by cesarean section at 38-42 weeks of gestation
- Absence of a maternal history of high-risk pregnancy, including eclampsia, preeclampsia, or gestational diabetes
Key exclusion criteria (5 listed)
- Birth weight below 2,500 g
- Birth weight of 4,000 g or above
- Apgar score below 7 at either 1 or 5 minutes after birth
- Presence of a congenital anomaly
- Admission to the neonatal intensive care unit during the early postnatal period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amniotic Fluid Odor Sterile Distilled Water OdorIn the intervention group, healthy newborns born by cesarean section will be exposed to the odor of their own amniotic fluid shortly after birth. Amniotic fluid collected during delivery will be applied to a sterile material and positioned near the newborn's nose without direct contact with the skin or airway. The intervention will be administered according to a standardized study protocol. The newborns' postnatal adaptation, physiological parameters, and stress responses will be assessed at predetermined time points. | Other | Amniotic Fluid Odor Group, Distilled Water Odor Exposure |
Primary outcome
Heart Rate:beats per minute
Time frame: At 30 minutes after birth
The newborn's heart rate will be measured using a pulse oximeter and recorded as beats per minute. Heart rate values will be compared between the amniotic fluid odor group and the sterile distilled water odor group.
Respiratory Rate: breaths per minute
Time frame: At 30 minutes after birth
The newborn's respiratory rate will be assessed by counting respiratory movements for one minute and recorded as breaths per minute. Respiratory rate values will be compared between the study groups.
Peripheral Oxygen Saturation:percentage
Time frame: At 30 minutes after birth
The newborn's peripheral oxygen saturation will be measured using a pulse oximeter and recorded as a percentage. Oxygen saturation values will be compared between the study groups.
Body Temperature: degrees Celsius
Time frame: At 30 minutes after birth
The newborn's body temperature will be measured using a digital thermometer and recorded in degrees Celsius. Body temperature values will be compared between the study groups.
1 secondary outcome
Neonatal Stress Level
Time frame: 30 minutes after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zekiye karaçam, prof study chair
Aydin Adnan Menderes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amniotic Fluid Odor Sterile Distilled Water Odor in people with Postnatal Adaptation and Stress in Healthy Newborns Born by Cesarean Section, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate:beats per minute (time frame: At 30 minutes after birth). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.